Pilot study using Fecal Microbiota Transplant (FMT) for recurrent or severe C. difficile infection in children

Principal Investigator: Dr. Lewis MD

Abstract:

Clostridium difficile (CDI) infection is an increasingly common cause of diarrheal illness in children. At Children’s Healthcare of Atlanta, we commonly see CDI as both a hospital acquired infection and as community acquired. Nationally, the rate of CDI is growing with an increase in the morbidity and mortality associated with CDI in adults and children felt to be due to broad antibiotic usage and also to the emergence of a newer, more virulent and resistant strain of bacteria. The most common risk factor for developing CDI is exposure to antibiotics; a common occurrence in pediatrics especially among many of the medically complex and chronically ill patients that comprise our patient population. The standard of care for treatment of CDI often requires prolonged courses of antibiotics and, in severe cases, may require hospitalization, gut rest, and parenteral nutrition in addition to multiple antibiotic regimens. The increasing morbidity and mortality are often associated with relapse and recurrence after initial successful treatment. Recurrence rates after a standard 10 day course of metronidazole or vancomycin are as high as 30-40% requiring even more courses of antibiotics and even more hospitalizations, especially in the medically complex patient. An alternative approach to eradicating CDI with antimicrobials is to restore the flora with fecal transplant therapy or fecal microbiota transplant (FMT). This approach has been successful in treating CDI in adult patients and, in smaller case series, in pediatric patients. We propose to evaluate a commercially available fecal donor preparation (Openbiome stool donor bank) in a prospective feasibility study to demonstrate that FMT is a viable, safe and potentially effective intervention in children who have relapsed after at least two courses of broad spectrum anti-C. difficile antibiotics. As a secondary goal, in collaboration with biomedical department at Georgia Tech, we plan to characterize the intestinal microbial flora before and after transplant in comparison with the donor sample

Purpose: This study is designed to prospectively treat and follow patients with recurrent CDI who qualify for FMT under the CHOA guidelines approved by the CHOA medical executive committee in March 2014. Our goal is to demonstrate safety and efficacy of FMT using Openbiome product in children who have recurrent CDI despite at least two courses of antibiotics including a prolonged course of vancomycin.